Synchronized eating for bipolar depression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot randomized trial will compare adjunctive 10-hour time-restricted eating (TRE) plus usual care to nutritional counselling plus usual care in adults with bipolar depression. The investigators aim to recruit 40 participants aged 18–55 with bipolar I or II disorder and current depressive symptoms, with an 18-month enrollment window and a target retention of at least 70%. Primary outcomes are feasibility and acceptability, measured as willingness to participate, dropout rates, and adherence to the assigned intervention; secondary measures will explore mood, metabolic, circadian, and cognitive outcomes. Results will inform the design of a future multi-centre randomized controlled trial if TRE appears feasible and acceptable.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Be 18-55 years old
2. Have a diagnosis of bipolar I or bipolar II disorder, confirmed by the Quick Structured Clinical Interview for DSM-5® Disorders, QuickSCID-5.
3. Have depression symptoms as indicated by a score of ≥12 on MADRS and ≤12 on YMRS.
4. Females of childbearing potential are willing to follow highly effective methods of contraception (mentioned below) for the duration of study\*
5. Participants must be able to speak, read, write and understand English or French.
6. Be willing and able to provide informed consent.

Exclusion Criteria:

1. Have any catatonic symptoms or eating disorder(s) as measured by the Quick Structured Clinical Interview for DSM-5® Disorders, QuickSCID-5.
2. Have any unstable or inadequately treated neurological and medical conditions.
3. Have had prior bariatric surgery. 4 Be taking hypoglycemia inducing medications.

5\. Be pregnant or lactating. 6. Currently taking any stimulant medications. 7. Be participating in any other diet or weight management program for the duration of the trial.

8\. Have any contraindication to fasting as judged by the assessing clinician. 9. Recently (i.e. within the past 8 weeks) began structured psychotherapy (i.e. cognitive-behavioral therapy, interpersonal psychotherapy, family-focused therapy, or interpersonal and social rhythm therapy).

10\. Have any other medical condition, substance use disorder or suicidal ideation for which physician or investigator team expresses concern about safety or ability to participate in the study.

Where it's running

• Ottawa Hospital Research Institute
  Ottawa, Ontario, Canada Recruiting

Study contacts

• Principal investigator: Gayatri Saraf, MD — The Ottawa Hospital
• Study coordinator: Deniz Ruscuklu, BA
• Email: deruscuklu@ohri.ca
• Phone: 613-737-8899

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.